The most recent clinical study of Xarelto (rivaroxaban) has been halted more than a year early, because Bayer AG, the drug’s original developer and sponsor of the trial, is satisfied with the results. That study, known as “Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease,” or COMPASS, was originally going to continue until March of 2018. However, Phase 3, which studied the efficacy of Xarelto in the treatment of patients at risk for serious coronary events or peripheral arterial disease, has met its primary endpoint ahead of schedule.
According to a press release from Bayer, the drug’s effectiveness in preventing coronary artery disease (CAD) and peripheral artery disease (PAD) has been confirmed and the study has been halted on a recommendation from an independent data monitoring committee (DMC). The purpose of such a committee is to determine whether or not the experimental part of a study should be continued or terminated, based on an analysis of risks vs. benefits. In order to stop a research study early, the statistics must clearly show that the benefits to patients outweigh the risks – even if those risks are serious ones.
Although it has been established that Xarelto can put patients at risk for uncontrolled and potentially fatal hemorrhaging, the DMC in this case has determined that the benefits to patients are greater than the risk of bleeding.
Today, over ten million people in the U.S. suffer peripheral artery disease, which can be an indicator of coronary artery disease as well. The condition may affect as many as one out of five adults over age 55 throughout the world. Early approval of Xarelto for the treatment of PAD would mean additional revenue for Bayer, who has been aggressively trying to expand the market for its product. Xarelto brought in approximately $2.25 billion in revenue during the first three-quarters of 2016 – an increase of 30% over the year before. Based on the recent success of the Phase 3 trial, Bayer is estimating that global Xarelto revenues could grow to $5.3 billion.
In the wake of the failure of a major clinical study for another PAD treatment last October (Brilinta, a product of AstraZeneca), the manufacturer as well as distributors Janssen and its parent company, Johnson & Johnson, are now looking at a market that is wide open. However, they still face a growing number of lawsuits over serious and fatal hemorrhaging caused by Xarelto (with approximately 15,000 cases either pending as of this writing) as well as other legal problems over alleged kickbacks to physicians.
According to Pro Publica’s Dollars for Docs website, Janssen Pharmaceuticals has paid out a total of $54.3 million in order to promote Xarelto. Between this and Xarelto’s track record for causing serious injuries, it will be difficult to convince PAD patients to agree to treatment with this medication.